Carotid Plaque Imaging Project (CPIP) (CPIP)

Carotid Plaque Imaging Project (Identification of Vulnerable Atherosclerotic Plaques With Imaging and Biological Markers)

The rupture or erosion of an atherosclerotic plaque with thrombosis or embolization often underlie heart attacks and strokes. The early identification of patients with atherosclerotic plaques prone to rupture or erosions, vulnerable plaques (VP), and their treatment before the occurrence of events is, therefore, one of the greatest cardiovascular challenges today. Possible approaches for early detection of VP include imaging techniques allowing visualization of plaque structure, circulating biomarkers and better understanding of the pathophysiologic mechanisms of the disease. In the carotid plaque imaging project the investigators study human atherosclerotic plaques (that are removed by endarterectomy) to disclose their underlying structure and mechanisms, finding possible novel therapeutic targets or markers for VP. The investigators also study plaque structure with imaging methods and try to develop new ways to detect VP using circulating or imaging markers.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerosis; Atherosclerotic Plaque
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Estimated): 3500

Contacts and Locations

• Study Contact: Name: Isabel Goncalves, MD, PhD; Phone Number: +46 40 331000; Email: Isabel.Goncalves@med.lu.se

Study Locations

• Sweden
  • Skåne
    • Malmö, Skåne, Sweden, 214 28
      • Recruiting
      • Skåne University Hospital (SUS)
      • Contact: Isabel Goncalves, MD, PhD; Phone Number: +46 40 331000; Email: Isabel.Goncalves@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with carotid stenosis undergoing endarterectomy at Skåne University Hospital (SUS), Malmö, Sweden.

Description

Inclusion Criteria:

• Patients older than 18 years old, male or female that are eligible for carotid endarterectomy due to atherosclerosis and that can provide informed consent.

Exclusion Criteria:

• Patients younger than 18 years old that cannot provide informed consent; pregnant.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carotid Plaque Imaging Project (CPIP)	Other: Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants suffering post-operative cardiovascular events (by 2025)	Post-operative myocardial infarction, stroke, transient ischaemic attack, amaurosis fugax, cardiovascular death (according to Swedish National Registers)	Follow up assessment year 2025 (recording of events occurring since 2023)
Number of participants suffering post-operative cardiovascular events (by 2027)	Post-operative myocardial infarction, stroke, transient ischaemic attack, amaurosis fugax, cardiovascular death (according to Swedish National Registers)	Follow up assessment year 2027 (recording of events occurring since 2025)
Number of participants suffering post-operative cardiovascular events (by 2029)	Post-operative myocardial infarction, stroke, transient ischaemic attack, amaurosis fugax, cardiovascular death (according to Swedish National Registers)	Follow up assessment year 2029 (recording of events occurring since 2027)

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: The Swedish Research Council; Region Skane; Swedish Heart Lung Foundation; Swedish Foundation for Strategic Research; Skåne University Hospital funds (incl. the Medical Training and Research Agreement/ALF)
• Investigators: Principal Investigator: Isabel Goncalves, MD, PhD, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2005
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Atherosclerosis; Plaque, Atherosclerotic
• Other Study ID Numbers: CPIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing allowed due to General Data Protection Regulation (GDPR) legislation as sensitive personal data is included.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No